Cosmetic Facility Registration.
The MoCRA OS. We handle Facility Registration (Form 5066), Product Listing (Form 5067), and Safety Substantiation in one unified platform.
Blocked by retailers?
Major beauty retailers now require proof of MoCRA registration as a condition of purchase. Without an FDA Establishment Identifier (FEI), you will be delisted.
The misbranding trap.
Cosmetics cannot make “drug claims” (e.g., “stimulates collagen”, “cures acne”). Our AI Label Auditor scans your packaging for prohibited language and missing elements.
- Drug Claim Detection (Anti-Aging vs Appearance)
- Ingredient Nomenclature (INCI format)
- Warning Statements (Safety)
- Contact Information (RP Address)
Who is the responsible person?
MoCRA defines the “Responsible Person” (RP) as the entity whose name appears on the product label. This entity is legally liable for safety substantiation and adverse event reporting.
Determine Your Role
Responsible Person Duties
- Facility Registration (if you manufacture)
- Product Listing (Annual Update)
- Safety Substantiation (Toxicology)
- Serious Adverse Event Reporting (15 Days)
- Labeling Compliance (Contact Info)
Toxicology screening.
We screen your formula against the FDA Prohibited List and EU Annex II. Don't let a hidden contaminant like Methylene Glycol trigger a mandatory recall.
Mandatory Recall Risk
FDA can now force a recall if they suspect “reasonable probability” of harm. Your safety data is your only defense.
FY 2026 Compliance
Prove it's safe.
Under MoCRA, you must possess “adequate substantiation” of safety for every product before it hits the market. FDA can request this data at any time.
The ”Adulterated“ Trap
If you cannot produce safety data upon request, your product is legally deemed “adulterated” and subject to immediate recall.
Good Manufacturing Practices.
MoCRA authorizes the FDA to inspect cosmetic facilities for GMP compliance. We provide the SOP templates and audit checklists you need to align with ISO 22716.
Get GMP templatesGap Analysis
Are you exempt?
If your average gross annual sales for the previous 3-year period is less than $1,000,000, you may be exempt from Facility Registration and Product Listing requirements.
Small Business Test
Average annual gross sales (3-year)
The 15-day clock.
You must report any “Serious Adverse Event” (death, infection, disfigurement) to the FDA within 15 business days. Our eMDR portal handles the XML submission instantly.
Brand & Manufacturer sync.
The “Responsible Person” (Brand) must list the product, but they need the Facility Registration Number (FEI) from the contract manufacturer. We bridge the data gap automatically.
Sync supply chainFragrance allergen disclosure.
MoCRA now requires the specific listing of fragrance allergens on the label, aligning US standards closer to the EU.
Limonene
Source: Citrus Oils
Linalool
Source: Lavender
Citral
Source: Lemon
Don't forget Prop 65.
MoCRA preemption does NOT apply to California Proposition 65. If your product contains Titanium Dioxide (airborne), Retinol, or 900+ other chemicals, you need a warning label.
Get Prop 65 checklistWARNING
This product can expose you to chemicals including [Titanium Dioxide], which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
FDA Category mapping.
MoCRA uses a specific set of product category codes (e.g. 05.A for Skin Care Oils). Choosing the wrong code can trigger a “Refusal to File”. We map your SKU to the correct FDA taxonomy.
Find my category codeYour boots on the ground.
If your facility is outside the USA, you MUST designate a U.S. Agent for FDA service of process. We provide this service included with your registration.
- 24/7 Emergency Response
- Inspection Scheduling
- Recall Coordination
- Official Service of Process
Official U.S. Agent
Pursuant to Section 607 of the FD&C Act, foreign facilities must designate a U.S. agent for FDA communications.
VCRP data did not transfer.
The old Voluntary Cosmetic Registration Program (VCRP) is dead. The FDA did not migrate any data to the new Cosmetics Direct portal. You must re-list everything from scratch.
Re-list my productsDigital Record Vault
MoCRA requires you to keep adverse event records for 6 years (3 years for small businesses).
6-year record retention.
MoCRA mandates that you maintain records of adverse events for 6 years (or 3 years for small businesses). Our secure vault keeps your data inspection-ready.
Secure your recordsNew mandatory authority
MoCRA gives the FDA unprecedented power to order recalls and suspend facility registrations.
Mandatory Recall
If FDA determines a 'reasonable probability' of serious adverse health consequences, they can force you to recall product immediately.
Registration Suspension
FDA can suspend your facility registration, effectively shutting down your ability to distribute in the USA.
Serious Adverse Events
You must report serious events (death, infection, disfigurement) to FDA within 15 business days.
Set it and forget it.
Cosmetic facility registrations must be renewed every two years. We automate this process so you never miss a deadline or risk suspension.
Enable auto-renewalGlobal export ready.
Leverage your FDA registration to obtain a “Certificate of Free Sale”, allowing you to export to 60+ countries including China, Brazil, and the Middle East.
Get export certificatesThe Registration Evolution
Stop fighting 2003-era government portals.
Frequently Asked Questions
Common questions about this regulatory requirement.
Secure Your Supply Chain.
Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.